Field Safety Notice: 01 to 05 April 2019
List of field safety notices (FSNs) from medical device manufacturers from 01 to 05 April 2019
Overview
If you receive a field safety notice (FSN) from a manufacturer you must always act on it.
MHRA publishes the following for information only.
If you have a question about a particular FSN contact the manufacturer.
Latest FSNs
View the latest FSNs
3M: 3M™ Reston™ Self-Adhering Foam
2 April 2019
Pressure relief cushions MHRA reference: 2019/004/002/701/006
Abbott: BrandHM3™ Outflow Graft, HM3™ LVAS Kit
01 April 2019
Implantable ventricular assist devices 105581INT, 106524INT MHRA reference: 2019/004/001/291/012
Abbott: Alinity hq Analyzer
29 March 2019
IVDs, haematology
MHRA reference: 2019/004/002/487/027
Draeger: Infinity Acute Care System (M540)
March 2019
Monitors, patient
MHRA reference: 2019/004/002/291/006
Edwards Life Sciences: Vamp Optima
FCA 127 Storage & collection devices MHD8VLTW, MHD8VRL5 and VOPTIMAL
MHRA reference: 2019/004/001/291/002
Elekta: Elekta Unity
March 2019
Radiotherapy
MHRA reference: 2019/004/002/291/005
GE: Giraffe Bedded Warmers, Panda iRes Warmers
FMI 32067 Infant incubators Giraffe Bedded Warmers, Panda iRes Warmers
MHRA reference: 2019/004/001/291/006
GE: Aysis, Aisys CS2
FMI 34098
Anaesthetic machines & monitors
MHRA reference: 2019/004/002/291/004
Hoggi: CLEO
18 October 2018
Wheelchairs, manual 3279-0032 MHRA reference: 2019/004/001/291/011
Johnson & Johnson: ILS Proximate Circular Stapler
24 June 2019
Staples and staple guns MHRA reference: 2019/003/028/701/016
Maquet (Getinge): 720001B2, 720001B0, 720001F2, 720001F0, 710001B2,
02 April 2019
Operating table
MHRA reference: 2019/004/002/487/028
Medtronic: DRILL MINI-TREPHINATION 2.0mm
March 2019
Surgical power tools
Model: 1882900
MHRA reference: 2019/003/029/487/004
Medtronic
April 2019 Implants, active, stimulators, neuro A610 MHRA reference: 2019/004/002/291/002
Molnlycke Health Care: Mölnlycke® Detachable EndoRetrieval Pouch
01 April 2019
Surgical instruments, minimal access
Model: 899103-01
MHRA reference: 2019/003/029/487/008
PREVOR: DIPHOTERINE
18 March 2019
Detergents Model: MINI-DAP & MICRO-DAP
MHRA reference: 2019/003/028/601/002
PROCEPT BioRobotics: AQUABEAM Handpiece
12 March 2019
Therapy tissue ablation
Model: 320301
MHRA reference: 2019/003/007/701/012
Roche: BILD2 (Bilirubin direct Gen.2)
March 2019
IVDs, clinical chemistry MHRA reference: 2019/003/029/701/006
Zimmer: Foot and Ankle Inst. (Drill / Tap and Countersink)
27 March 2019
Various devices affected
MHRA reference: 2019/004/002/291/003